Events

Notificaciones De Seguridad De Campo acerca de Simplexa™ Flu A/B & RSV Direct assay Simplexa™ HSV 1 & 2 Direct assay

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Focus Diagnostics.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2014-05-15
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    The purpose of this letter is to advise you that focus diagnostics is providing an urgent safety notice for a correction to the labeling for simplexa™ flu a/b & rsv direct (mol2650) and simplexa™ hsv 1&2 direct assays (mol2150). focus diagnostics received some customer complaints of simplexa flu a/b & rsv direct assays with sporadic false signals, which may result in a higher false results rate due to a potential software spectral matrix and direct amplification disc storage. to date, focus has not received any complaints for the simplexa hsv 1 & 2 direct assay used for commercial use. focus diagnostics is not requesting removal of any products from the test facility, but you should take extra precautions as described in the updated labeling. .

Device

Simplexa™ Flu A/B & RSV Direct assay Simplexa™ HSV 1 & 2 Direct assay

Manufacturer

Focus Diagnostics